Today the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance. To access the Federal Register notice announcing the availability of the final guidance document go to: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf or https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm To access a copy of the final guidance document go to: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html
Thank you in advance for your assistance with facilitating SUNY Pre-Award and Compliance System (PACS) training registration at your campus. SUNY PACS training course sessions for the Agreements, COI and IRB modules will be held throughout November 2016. Post-training support and ask-the-expert office hours will be provided as needed for your campus staff.
Detailed information is now available in two locations: · myRF: Visit the SUNY PACS Training page to review course information by module or view a complete calendar of training events. Both formats contain course descriptions, training materials and links to register.
1. Invite all appropriate RF/SUNY audiences on your campus to review the available courses and register. A message template is below that may be helpful to forward your contacts; modify at your discretion.
SUNY Pre-Award and Compliance System (PACS) training sessions for the Agreements, COI and IRB modules will be held throughout November 2016. All training courses will be 60-minute, instructor-led sessions conducted by WebEx. Post-training support and ask-the-expert office hours will be provided as needed once you begin using the tool. To view course information, access meeting materials and register for training visit:
IRB Training Video:
http://www.newpaltz.edu/sponsored_programs/pacs.html
PACS Training videos:
http://www.rfsuny.org/Our-Work/RF-Projects-/SUNY-Pre-Award-and-Compliance-System-PACS/PACS-Training-Videos-/
http://www.rfsuny.org/Our-Work/RF-Projects-/SUNY-Pre-Award-and-Compliance-System-PACS/PACS-Training-Videos-/
Today the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance. To access the Federal Register notice announcing the availability of the final guidance document go to: https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf or https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm To access a copy of the final guidance document go to: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html
Irene Stith-Coleman Irene.Stith-Coleman@hhs.gov via list.nih.gov
Training
https://myrf.rfsuny.org/projects/PACS/Train/Pages/default.aspxSUNY Pre - Award and Compliance System (PACS) Newsletter
http://sunyrf.informz.net/SUNYRF/data/images/SUNY%20PACS/SUNY%20PACS%20Newsletter.%20August.pdfThank you in advance for your assistance with facilitating SUNY Pre-Award and Compliance System (PACS) training registration at your campus. SUNY PACS training course sessions for the Agreements, COI and IRB modules will be held throughout November 2016. Post-training support and ask-the-expert office hours will be provided as needed for your campus staff.
Detailed information is now available in two locations:
· myRF: Visit the SUNY PACS Training page to review course information by module or view a complete calendar of training events. Both formats contain course descriptions, training materials and links to register.
Note: Users who do not already have a myRF user account can request one by sending an email to email to //customerservices@rfsuny.org//
· RF Public Website: View the complete PACS Module Training Course Catalog and Calendar (PDF) with course descriptions, training materials and links to register.
Action Requested:
- 1. Invite all appropriate RF/SUNY audiences on your campus to review the available courses and register. A message template is below that may be helpful to forward your contacts; modify at your discretion.
If you have questions, please contact Kelly Kowalski at (518) 434-7258 or Kelly.kowalski@rfsuny.orgThank you,
PACS Team
Message template
Please forward to appropriate campus staff.
SUNY Pre-Award and Compliance System (PACS) training sessions for the Agreements, COI and IRB modules will be held throughout November 2016. All training courses will be 60-minute, instructor-led sessions conducted by WebEx. Post-training support and ask-the-expert office hours will be provided as needed once you begin using the tool. To view course information, access meeting materials and register for training visit:
- myRF: Visit the SUNY PACS Training page to review course information by module or view a complete calendar of training events. Both formats contain course descriptions, training materials and links to register.
ORNote: If you do not have a //myRF// user account, send a request to //customerservices@rfsuny.org//